(252 days)
The InfraReDx NIR System is intended for the near infrared imaging of the coronary arteries.
The InfraReDx Near Infrared (NIR) Imaging system is comprised of the catheter, catheter accessories, pull-back and rotation device and laser console with accessories.
Here's a breakdown of the acceptance criteria and study information for the InfraReDx Near Infrared (NIR) Imaging System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards Compliance: | Complies with ISO 60601-1, ISO 60601-2-22, CSA22.2 No.601.1, CSA Z386-01, IEC 60825-1, ANSI Z136.1-2000, and ISO 10993 (for transient blood contacting devices). |
| Intended Functionality: | Preclinical testing has shown that the product can function as intended. |
| Internal Design Specifications: | Preclinical testing has shown that the product meets all internal design specifications. |
| Substantial Equivalence to Predicate Devices: | The device has similar indications statements and identical functionality to predicate devices for imaging coronary vasculature. Its output (image of the artery) as an adjunct to coronary angiography is similar to predicate devices. |
Study Details:
Based on the provided 510(k) summary, the device's acceptance was primarily based on adherence to established safety and performance standards for medical devices and a demonstration of substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic accuracy against a specific ground truth.
Here's an analysis of the requested information:
2. Sample Size Used for the Test Set and Data Provenance:
The document describes preclinical testing to demonstrate compliance with standards and internal design specifications. It does not mention a "test set" in the context of clinical data for diagnostic performance. Therefore, there is no sample size or data provenance (country of origin, retrospective/prospective) for a diagnostic test set in the provided summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The submission focuses on device safety and functional conformity through preclinical testing and comparison to predicate devices, not on a study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set:
Not applicable. There is no diagnostic test set described in the provided information that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No. The document does not mention an MRMC comparative effectiveness study or any data on how human readers improve with or without AI assistance. The device is for NIR imaging, not an AI-assisted diagnostic tool in the sense of interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The device is an imaging system, not an algorithm, and its performance is evaluated in terms of its ability to produce images and meet safety standards.
7. The Type of Ground Truth Used:
The "ground truth" implicitly used for this submission is related to:
- Compliance with recognized electrical, mechanical, and biological safety standards (e.g., ISO, CSA, IEC, ANSI).
- Adherence to the manufacturer's own internal design specifications.
- Functional similarity to already legally marketed predicate devices.
There is no mention of a ground truth for diagnostic accuracy (e.g., pathology, outcomes data, or expert consensus on image interpretation) in the context of a clinical study.
8. The Sample Size for the Training Set:
Not applicable. This device is an imaging system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm mentioned.
Summary of the Study's Nature:
The 510(k) submission for the InfraReDx Near Infrared (NIR) Imaging System, Model MC-5, primarily relies on demonstrating substantial equivalence to legally marketed predicate devices. This is a common pathway for medical devices that are similar in technology, intended use, and performance characteristics to devices already on the market.
The "performance data" cited in the summary revolves around:
- Compliance with a comprehensive list of international and national safety and performance standards for medical electrical equipment, laser safety, and biocompatibility.
- Preclinical testing to confirm that the device functions as intended and meets its internal design specifications.
The submission does not involve a clinical efficacy study, a multi-reader study, or the use of AI/ML algorithms requiring training and test sets with expert-adjudicated ground truth. Its acceptance criteria are based on fundamental safety, performance, and equivalence to existing technologies.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).